New CE Marked Prognostic Claim for the VerifyNow P2Y12 TestBy Accumetrics Inc., PRNE
Monday, May 16, 2011
Accumetrics' Platelet Reactivity Test Achieves CE Marking for Identifying Patients at Greater Risk of Recurrent Cardiovascular Events
SAN DIEGO, May 17, 2011 - Accumetrics, Inc., developer of the VerifyNow(R) System, the first rapid
and easy-to-use point-of-care system for measuring platelet reactivity to
multiple antiplatelet agents, announced today that the VerifyNow P2Y12 Test
is now CE marked for prognostic use in identifying patients with high
residual platelet reactivity (also termed poor responders) on antiplatelet
therapy (e.g. clopidogrel) who are at greater risk for future cardiovascular
Numerous studies have demonstrated the link between high residual
platelet reactivity and greater risk of ischemic events. Studies comprising
over 3,000 patients, utilizing the VerifyNow P2Y12 Test, have shown a
correlation to clinical outcomes based on PRU (P2Y12 Reaction Units) results,
concluding that an on-treatment PRU of greater than or equal to 230
identifies patients at significantly greater risk for future cardiovascular
events including death, heart attack and stent thrombosis.
"Researchers, such as myself, have long been studying the relationship
between platelet reactivity while on antiplatelet therapy and the risk of
recurrent ischemic events in our cardiovascular patients," stated Robert F.
Storey, MD, Professor of Cardiology at the University of Sheffield, England.
"The VerifyNow P2Y12 Test offers a simple and rapid means of assessing an
individual's response to antiplatelet medication. The achievement of a
prognostic claim will reinforce its application to risk stratification,
potentially guiding therapy in patients undergoing coronary stenting."
"The CE mark for prognostic use of the VerifyNow P2Y12 Test in risk
assessment represents a major milestone for Accumetrics," said Timothy I.
Still, President and CEO of Accumetrics. "Also considering the recent
inclusion of platelet reactivity testing in both the ACCF/AHA UA/NSTEMI
Guidelines and the STS/SCA Blood Conservation Guidelines, the VerifyNow
System is making a significant impact on how physicians are treating their
The VerifyNow System is widely used in various clinical settings where
antiplatelet medications are prescribed to reduce the occurrence of future
thrombotic events such as heart attack and stroke. The VerifyNow P2Y12 Test
is not currently indicated for use in risk assessment in the United States.
CE marking of this use is recognized in the European Economic Area.
Accumetrics is committed to enhancing quality of care for patients
receiving antiplatelet therapies by providing widely accessible diagnostic
tests for rapid assessment of platelet reactivity. The VerifyNow brand is the
most widely studied and recognized brand in the field of platelet reactivity.
Accumetrics' VerifyNow System helps physicians determine an individual's
platelet response to multiple antiplatelet agents. Addressing every major
antiplatelet drug including aspirin, P2Y12 inhibitors (e.g. prasugrel
(Effient(R)) and clopidogrel (Plavix(R))), and GP IIb/IIIa inhibitors (e.g.
ReoPro(R) and Integrilin(R)), the VerifyNow System provides valuable
information to help physicians make informed treatment decisions. For more
information about the Company and its products, visit
The Accumetrics logo and VerifyNow are registered trademarks of
Accumetrics, Inc. ReoPro is a registered trademark of Eli Lilly and Co.
Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is
a registered trademark of sanofi-aventis. Effient is a registered trademark
of Eli Lilly and Company.
CONTACT: Jakob Jakobsen +1-310-309-1003 firstname.lastname@example.org Timothy I. Still President and CEO Accumetrics +1-858-404-8260 email@example.com
Tags: Accumetrics Inc., california, May 17, San diego, Western Europe